A reader sent an article from The Pink Sheet (an industry rag focused on Pharma). If you’ve never read industry-specific news publications, you’re really missing out. They’re really facinating and instructive. Sometimes you get early knowledge about industry trends and others, if you’re lucky, that are not so subtle messages to other readers. This is one of the latter($ required, sorry).

The article is entitled “FDA Staffing Problems Extend Beyond Funding Shortfalls; Culture Shift Sought.” I was expecting an article about what changes employees saw as need to change the culture. I was wrong. It’s covering a Summit for Biopharma Execs and the culture shifts that industry wants.

Part 1. “FDA Needs Direct Hiring Authority”. This goes into how there are so many positions open in the FDA but they can’t fill them because HHS took FDA’s ability to hire it’s own staff to make things more consistent and streamlined. Guess how well that worked. So most applicants get better job offers way before they even hear from the agency. The article says about this:

“This is a real opportunity for the pharmaceutical executives to go to [the Office of Management and Budget] and see if they could get direct hiring authority at the agency” Gottleib suggested

Hint, hint.

“It would be a good test to see just how politically potent this industry is with Bush White House”

HINT, HINT!

Why they don’t just cut the wink and nod and have a itemized homework list at the bottom I don’t know. There’s a more sections on the fact that there are fewer applicants with specialized skills and that the low salaries at the FDA make it hard to keep people. Then comes another good section: “Consensus on Safety a Major Issue”. According to Arnold & Porter Senior Council William Vodra:

FDA operates in “a climate in which every decision can be challenged as being improperly made”

Horror!

Refering to the fact that now that the reviewers of drugs (MDs and PhDs, mind you), he continues with this complaint:

Power is moving lower and lower in the agency as staff “are not accountable to leadership”

*I totally agree. Where is that iron fist of old? That grand tradition of political interferrence into the science and ethics questions that the reviewers grapple with? Where is the opaque decision making process? We have no use for these new fagled concepts of transparancy. It’s not like the FDA is supposed to work for the public. They are supposed to work only for Pharma! I do not like this turn of things. And lastly, why oh why does FDA even have a press office? They should just have a tape recorder that says “You’re safe, we’re doing a heckuva job, drug companies are the best, no further comment”.

The last paragraphs are “Internal Dissent Undermines Pulic Confidence” and “Whistleblower Protections May Be Expanded” but I think you get the idea already so I’ll stop here.

Comments

This is a very tough issue. Historically, the FDA has tried to avoid conflicts fo interest in its inspectors by hiring people without any direct industry experience, often right out of school. This does indeed reduce conflict of interest problems, but it also results in inspectors who usually do not understand the industry or the technology well enough to conduct a genuinely meaningful inspection. So far too many of the inspections we do get are primarily focused on paperwork details, some generic systems, and “what everyone else is doing”, and have little to do with the actual practices that really matter for making safe and effective medicines.

Modern medicine really is complex enough that there is no good way to understand the state of the art without working in it and on it for a while. But that of course does raise the possibilities of conflict of interest. I don’t really have any good answers for this, but I think it is important to at least be aware of the problem.

I have no problem with a revolving door at the FDA as long as it doesn’t turn too quickly. People with experience with both sides could really help, especially if they start at the FDA. What’s silly is that industry wants everything at the FDA to be run Top-down. And that’s code for political interferrence since the top is politically appointed.